A comparative analysis of Namibia's medicines regulatory authority with regulatory authorities of South Africa, the United States of America, and the United Kingdom
1 WAP Pharmacare Group of Pharmacies, Oshana Region, Namibia.
2 Department of Pharmacy, Oshakati Intermediate Hospital, Ministry of Health and Social Services, Oshana Region Directorate, Namibia.
Research Article
GSC Biological and Pharmaceutical Sciences, 2024, 28(02), 090–098.
Article DOI: 10.30574/gscbps.2024.28.2.0288
Publication history:
Received on 23 June 2024; revised on 04 August 2024; accepted on 06 August 2024
Abstract:
Background: Little attention has been paid to the principle of the independence of medicine regulatory authorities, agencies, or boards, especially in Africa, despite their role in ensuring the availability of safe, effective, and affordable pharmaceuticals to society.
Methods: Data was collected using information from the Acts, Laws, legislation, and regulations available in the public domain. Standard Gilardi and INDREG questionnaires were used to collect data to assess the legal status, adequacy of human and financial resources, role clarity, transparency, and accountability of regulators, which could be answered through desk research.
Findings: The average overall independence for all four agencies is 59%, with a standard deviation of 10%. The study results further revealed that the national regulatory authorities have significant protection above average from external influence though they are not entirely independent.
Conclusion: The four agencies have comparable regulatory independence and similar protection from undue external influence. Namibia's medicines regulatory independence level is not significantly different from that of South Africa, the United Kingdom (UK), and the United States of America (U.S.A).
Keywords:
Regulatory Authorities; Governance; Independence; Global Benchmarking Tool; Regulatory Independence; Independent Regulatory Authorities
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